Position overview

The Clinical Trials Pharmacist works as part of the Pharmacy Clinical Trials Team to support the safe, efficient and compliant conduct of clinical trials across Canberra Health Services. This position is responsible for operational and clinical activities relating to investigational medicinal products (IMPs), including receipt, storage, accountability, dispensing, documentation, and liaison with trial coordinators, investigators, and patients.

Working under the limited direction of the Senior Pharmacist – Clinical Trials, the role ensures pharmacy services to clinical trials meet relevant legislative frameworks, research governance requirements, GCP (Good Clinical Practice) principles, and sponsor protocol specifications.

The role also contributes to broader departmental services, including rostered weekend, public holiday, and after-hours clinical pharmacy services.

Key Responsibilities

Specific responsibilities include, but are not limited to, the following:

The responsibility of this position is to provide clinical and operational pharmacy services that support the provision of clinical trials at Canberra Hospital.

1. Provide operational pharmacy services to support the conduct of clinical trials, including receipt, storage, temperature monitoring, accountability, and dispensing of IMPs in accordance with protocol and GCP requirements.
2. Ensure accurate and timely completion of all pharmacy trial documentation (e.g., accountability logs, delegations, variance records, destruction processes).
3. Participate in trial initiation, site qualification, monitoring and close‑out activities as required.
4. Review pharmacy trial manuals and study protocols, identifying operational requirements and escalating questions or risks to the Senior Clinical Trials Pharmacist.
5. Provide clinical and technical advice relating to investigational products, including storage conditions, preparation instructions, interactions and stability considerations.
6. Provide patient counselling relating to trial medicines where required, ensuring clear communication and protocol adherence.
7. Contribute to clinical trials–related working groups and act as an effective liaison between the Pharmacy Department, Principal Investigators, Research Office, trial coordinators and external sponsors.
8. Assist in ensuring compliance with CHS policies, national/international trial standards, and regulatory obligations governing the supply of IMPs.
9. Contribute to audits, temperature excursions investigations, corrective/preventative actions, and continuous quality improvement activities within the trials service.
10. Support trial‑related medication safety initiatives and participate in accreditation or governance activities associated with research services.
11. Provide supervision and guidance to intern pharmacists, students, and pharmacy technicians working within the clinical trials team.
12. Contribute to training of pharmacy staff, nursing staff or research teams regarding clinical trials processes and safe handling of IMPs.
13. Maintain own competence in clinical trials pharmacy practice, regulatory frameworks and GCP, participating in ongoing professional development.
14. Provide a range of pharmacy services on weekends, public holidays and after hours as rostered, including participating in an On-Call roster and working across hospital sites as necessary.
15. Undertake other duties appropriate to this level of classification which contribute to the operation of the organisation.

Competencies

Specific responsibilities include but are not limited to the following.

For a level 2 pharmacist position increment - able to demonstrate competency against the National Standards for Advanced Pharmacy Practice at the Transition Level.

For a level 3 pharmacist position increment - able to demonstrate competency against the National Standards for Advanced Pharmacy Practice at the Consolidation Level, which may include a post graduate qualification at diploma level or above.

The competencies defined within the National Competency Standards Framework for Pharmacists in Australia¹ describes 5 Domains. The competency level required within these domains for this role is at the advanced practice level.

• Domain 1: Professionalism and ethics: To comply with legislative standards, including a legal responsibility to work within their competence, and commit to life-long learning and professional development to maintain and build competence. Uphold ethical standards, demonstrate the professional behaviours reasonably expected of a registered health professional and strive to improve quality and safety within the health system. Able to apply expert knowledge and skill, use reasoning and judgement, demonstrate accountability and responsibility use professional autonomy at an advanced level.

• Domain 2: Communication and collaboration: To communicate and work effectively with professional colleagues, patients (which includes carers, guardians and families), other clients as well as members of the general public. Able to work across workplace boundaries, provide expert advice and collaborate effectively at an advanced level.

• Domain 3: Medicines management and patient care: Apply their expertise to promote wellness or work in direct consultation with patients or in collaboration with other health professionals to improve health. Including participation in public health and health promotion activities, the assessment of patients to develop a patient-centred medication management plan and the provision of medicines (prescription and non-prescription) and compounded products. Able to demonstrate the ability to assess complex clinical situations and make informed decisions regarding medication management.

• Domain 4: Leadership and management: Demonstrate self-leadership as well as their leadership role in sharing a vision for the future and promoting the use of initiative and innovation to respond to change and drive progress. This includes applying management skills to undertake organisational and business planning, including the management of finances, human and other resources, the professional environment and the service delivery arrangements at an advanced level.

• Domain 5: Education and research: To contribute to the education of professional colleagues. Including the ability to analyse and synthesise information from medical and pharmaceutical literature, identify and respond to gaps in the evidence-base by conducting research, share research findings and apply evidence in practice at an advanced level.

Reference: 1. National Competency Standards Framework for Pharmacists in Australia. Pharmaceutical Society of Australia. 2016.

Qualifications

Essential

• Be registered or eligible for registration as a Pharmacist with the Australian Health Practitioner Regulation Agency (AHPRA).
• Have experience with Good Clinical Practice
• Have an understanding of how the National Safety and Quality Health Service (NSQHS) indicators align with this role.

Desirable

• Membership of a professional organisation linked to the area of specialty.
• Postgraduate qualifications, in areas such as Clinical Pharmacy, Management, Education or Research, or relevant field, or experience deemed equivalent.

Experience

Essential

• Minimum of 3 years’ experience as a hospital pharmacist.
• Experience of working professionally as a registered pharmacist in an Australian hospital environment (or in a country where reciprocal arrangements apply with the Australian Pharmaceutical Council Competency Stream Skills Assessment method).
• Ability to apply relevant competency standards at PH2 Transition or PH3 Consolidation level to clinical trials practice.

Desirable

• Previous experience in clinical trials, investigational product management or research services.
• Experience contributing to quality improvement, audit, or policy development within a pharmacy or clinical governance context.
• Research experience and/or publication in peer reviewed journals
• Experience or knowledge of the CHS Exceptional Care Framework, and all other related frameworks.

Prior to commencement

Appointment to this position is conditional on being granted and retaining appropriate clearances:

• Pre-employment National Police Check.
• Comply with Canberra Health Services Occupational Assessment, Screening and Vaccination policy.
• Comply with CHS credentialing and scope of clinical practice requirements for allied health professionals.

Important information

All employees are required to:

• Adhere to the Canberra Health Services Values and the ACT Public Service Code of Conduct.
• Act in accordance and comply with all relevant Safety and Quality policies and procedures.
• Comply with all relevant clinical and/or competency standards.
• Be available for weekend and after-hours work.

CHS is leading the drive to digitally transform health service delivery in Australia through the implementation of a territory wide Digital Health Record. Computer literacy skills are required which are relevant to this role as you will be responsible for completing required documentation and becoming a proficient user of the Digital Health Record and/or other Information Technology systems; once proficient, you will need to remain current with changes, updates, and contingencies.

What you Require (Key Selection Criteria)

These are the key selection criteria for how you will be assessed in conjunction with your resumé and experience.

1. Demonstrated understanding of clinical trials pharmacy practice, including IMP handling, GCP principles, protocol requirements and research governance processes, with ability to apply these safely and accurately under limited supervision.
2. Proven ability to provide high-quality clinical and operational pharmacy services, including dispensing, checking, and providing medicines information relevant to investigational products.
3. Highly developed communication skills with the ability to liaise effectively with investigators, research coordinators, sponsors and multidisciplinary teams, maintaining positive and productive working relationships.
4. Demonstrated ability to provide professional supervision to junior pharmacists, graduates, students and support staff, a commitment to continuing professional development and contribute to education and training activities.
5. Demonstrated experience of significant contribution to the development, implementation or maintenance of improvement programs, policy and procedures and medication safety initiatives. This may include participation in research initiatives and accreditation activities.
6. Demonstrates understanding of, and adherence to, safety and quality standards, Work Health and Safety and the positive patient experience. Displays behaviour consistent with CHS’s values of reliable, progressive, respectful, and kind.

Work environment description

The following work environment description outlines the inherent requirements of the role and indicates how frequently each of these requirements would need to be performed. Please note that the ACT Public Service is committed to providing reasonable adjustments and ensuring all individuals have equal opportunities in the workplace.